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Healthy Skepticism Library item: 19604

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Bita N
TGA told to open up and get on front foot
The Australian 2011 July 21

Full text:

AUSTRALIA’S medicines watchdog is set for a shake-up after an inquiry criticised its secrecy and inefficiency.

An eight-month investigation into the Health Department’s Therapeutic Goods Administration has called on the industry-funded regulator to publish the results of all its safety investigations, and improve the way it gathers and reports the side-effects of medicines and vaccines.

The inquiry’s report, released yesterday, says the TGA should investigate putting a new “black triangle” logo on the packets of all new medicines, to warn the public that the safety of newly approved drugs has yet to be proven in the marketplace.

It concludes that Australians know more about US regulator the Food and Drugs Administration than their own TGA.

“It’s a worry,” said the head of the inquiry, former commonwealth ombudsman Dennis Pearce.

“Even among health industry people, they seemed to find it easier to get information from the FDA website than to find out things that are happening with the TGA.

“The TGA should be listening to what people want and meeting their requests but there has been a tendency to not pay as much heed to the needs of consumers for some time now.”

Professor Pearce called for some taxpayer funding of the TGA, the world’s only industry regulator entirely funded through levies on the pharmaceutical sector. The TGA was funded by taxpayers until 1998, when the Howard government switched to full cost recovery.

He said the TGA should publish the agendas and minutes of its advisory committees, subject to commercial confidentiality restrictions.

“They do practise a fairly strict conflict of interest process (but) we have suggested that conflicts of interest (among TGA advisers) be made clearer and be announced,” he said.

The report concludes that “the expectations of the public are not being met”.

“The TGA should adopt a proactive stance to the many issues relating to therapeutic goods that are of concern to the public it serves,” it says.

“It should move away from the conservative approach that has characterised its actions in the past.”

The report says the TGA has an ongoing responsibility to monitor the safety of products after it approves their use, and let the public know about any new information that “changes the risk-benefit ratio”.

“It is also essential that the TGA’s independence from sponsors and fairness in decision-making be reinforced by openness in its dealings,” it says.

The report says the TGA should let the public search its database of “adverse events” to drugs and vaccines.

It says the public does not understand that the TGA does not individually assess “low-risk” medical products, but relies on information from the manufacturers. Complementary medicines, such as vitamins and other alternative health products, are not evaluated by the TGA at all.

Consumer Health Forum chief executive Carol Bennett — a member of the inquiry, which included representatives of the Australian Medical Association, the pharmaceutical industry and consumer groups — yesterday called on the government to make the changes recommended.

“There’s been too much secrecy about what the TGA does,” she said.

“It is time they had some transparency and accountability.”

A spokesman for Parliamentary Secretary for Health Catherine King said the government was still considering the findings.


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